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Baclofen 5 mg/mL Suspension — NDC 52536-0600-12 package photo

Baclofen 5 mg/mL Suspension

by Wilshire Pharmaceuticals, Inc. · 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE
NDC 52536-0600-12
🏷️ FDA NDC (as labeled) 52536-600-12 billing pads the product segment with a zero
This package
Contains300 mL in 1 bottle Cost per mL$3.80 NADAC Per package$1,140.48 / 300 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.68/unit · Part D plans $4.91/unit — full pricing hub ↓
Also comes in: 120 mL 52536-0600-11
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 26, 2025 — Presence of Foreign Tablets/Capsules (Golden State Medical Supply Inc.) · FDA recall D-0235-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 52536-600-12
Product NDC 52536-600
11-digit billing NDC 52536060012
NCPDP billing unit ML — per mL (volume)
RxCUI 2593376
UNII H789N3FKE8
Application # NDA215602
SPL Set ID 4585aafe-0af8-4786-a419-6a7e76671ca2
Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist
Mechanism of action GABA A Agonists; GABA B Agonists
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-01
Route ORAL
Dosage form SUSPENSION
Substance BACLOFEN
GPI-14 75100010001825
GCN Seq No 083047
GCN 51885
HICL code 001949
Ingredient (HICL) Baclofen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.12.00
AHFS class Gaba-Derivative Skeletal Muscle Relaxant
FDB label name BACLOFEN 25 MG/5 ML SUSPENSION
FDB brand name Baclofen
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 52536-600-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52536-0600-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.

Pharmacologic class gamma-Aminobutyric Acid-ergic Agonist
Drug family (ATC) Other centrally acting agents
How it works GABA B Agonists, GABA A Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerWilshire Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA215602 (NDA AUTHORIZED GENERIC)
Labeler code52536
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio37 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BACLOFEN 25 MG/5 ML SUSPENSION Ingredient Baclofen
📗 Our plain-language guide HelloPharmacist
  • Baclofen is prescribed to reduce spasticity — the muscle stiffness, spasms, and rigidity that come with conditions like multiple sclerosis or spinal cord injury. Oral forms are als...
  • What exactly is baclofen being used to treat — and will it help my pain too?
  • Yes, and this is really important. Stopping baclofen suddenly — especially the pump form — can cause a dangerous withdrawal reaction: your spasticity can return much worse than bef...
  • I heard you can't just stop taking baclofen — is that really true?
📖 Read our full Baclofen guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $3.802 $1,140.48 / 300 ml
Medicaid paysCMS SDUD · 12 mo $3.68 $1,104.12 / 300 ml
Medicare drug plans payPart D · Q2 2026 $4.91 $1,474.32 / 300 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $3.802 $3.257
▲ Up 9% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baclofen 5 mg/mLthis 52536-0600-12 Wilshire 1 bottle $3.802 AB Availability likely —
Baclofen 5 mg/mL 62559-0204-03 ANI 1 bottle $3.802 AB Availability likely —
Fleqsuvy 5 mg/mL 52652-6001-01 Azurity 1 bottle $5.982 AB Availability likely +57%
Baclofen 5 mg/mL 71225-0140-01 Slayback 1 bottle — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Feb 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 4, 2022 AB TE-rated RLD RS ⏳ ~11 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11446246 — method of use (U-3433)
US 11324696 — drug product
2022 2024 2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 11446246 ↗ Method of use U-3433 Sep 8, 2037
US 11324696 ↗ Drug product — Sep 29, 2037
Common questions
Is there a generic version of BACLOFEN 25 MG/5 ML SUSPENSION?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BACLOFEN 25 MG/5 ML SUSPENSION. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 52536-0600-12, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.3K
Units reimbursed last 4 qtrs
1.6M
Gross reimbursed last 4 qtrs
$5.74M
Avg / prescription
$907.77
Avg / unit
$3.6804
Latest quarter Q1 2026
1.7KRx
Medicaid pays / mL
$3.6804
gross reimbursed
vs
NADAC / mL
$3.8016
acquisition cost
=
Spread
−$0.1212
-3% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 2,671 Rx Managed care · 3,648 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 18,615 units · 238 per 100k residents WA Idaho: 25,736 units · 1,310 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 2,760 units · 48.1 per 100k residents MN Wisconsin: 43,317 units · 733 per 100k residents WI Michigan: 24,631 units · 245 per 100k residents MI New York: 119,657 units · 611 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 4,017 units · 125 per 100k residents IA Illinois: 21,966 units · 175 per 100k residents IL Indiana: no data reported IN Ohio: 103,432 units · 878 per 100k residents OH Pennsylvania: 133,220 units · 1,028 per 100k residents PA New Jersey: 3,465 units · 37.3 per 100k residents NJ Massachusetts: 3,290 units · 47.0 per 100k residents MA California: 276,447 units · 709 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 4,710 units · 76.0 per 100k residents MO Kentucky: no data reported KY West Virginia: 4,593 units · 259 per 100k residents WV Virginia: 16,315 units · 187 per 100k residents VA Maryland: 20,642 units · 334 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 317,087 units · 4,267 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 24,725 units · 347 per 100k residents TN North Carolina: 120,033 units · 1,108 per 100k residents NC South Carolina: 50,990 units · 949 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 17,464 units · 382 per 100k residents LA Mississippi: no data reported MS Alabama: 13,488 units · 264 per 100k residents AL Georgia: no data reported GA D.C.: 10,545 units · 1,553 per 100k residents DC Hawaii: no data reported HI Texas: 111,510 units · 366 per 100k residents TX Florida: 65,930 units · 292 per 100k residents FL
Units reimbursed · per 100k residents
37.34,267
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 4,267 /100k
2 D.C. 1,553 /100k
3 Idaho 1,310 /100k
4 North Carolina 1,108 /100k
5 Pennsylvania 1,028 /100k
6 South Carolina 949 /100k
7 Ohio 878 /100k
8 Wisconsin 733 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle52536-0600-11 17,433 Rx · $12,708,590
1 bottle this page52536-0600-12 6,319 Rx · $5,736,169
Drug total (last 4 qtrs): 23,752 Rx · 4,813,385 units · $18,444,759 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Baclofen — the program that covers self-administered drugs. 23 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Baclofen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.67M
Claims incl. refills
1.3M
Beneficiaries
744.4K
Spend / beneficiary
$30.45
Spend / claim
$17.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Baclofen — the ingredient across all brands.

Top reported reactions

Fatigue6,296
Pain5,852
Fall5,569
Nausea4,756
Headache4,525
Gait Disturbance4,179
Dizziness3,650

Reporter sex

0 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization28,757
Death6,566
Life-threatening2,815
Disabling2,171
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,707 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
52536-0600-11 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE $3.77 / mL $452.17 2023-04-01 Active
52536-0600-12 You're viewing this 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE $3.80 / mL $1,140.49 2023-04-01 Active

This pack accounts for about 27% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 52536-0600-12?
NDC 52536-0600-12 is listed by the FDA — 1 bottle in 1 carton / 300 ml in 1 bottle.
What NDC number is used to bill for this package of Baclofen 5 mg/mL Suspension?
Bill NDC 52536-0600-12 — the 11-digit billing format is 52536060012. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 142 words ▾

1 INDICATIONS AND USAGE Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Baclofen is a concentrated formulation. Verify the dose of the product prior to dispensing. ( 2.1 ) Initiate baclofen with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) When discontinuing, reduce the dosage slowly. ( 2.3 )

2.1Important Information Baclofen is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering.

2.2Recommended Dosage Initiate baclofen with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) three times a day for three days 2 mL (10 mg) three times a day for three days 3 mL (15 mg) three times a day for three days 4 mL (20 mg) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times a day].

2.3Administration Instructions Shake well baclofen oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.

A household teaspoon or tablespoon is not an adequate measuring device. Nasogastric Tube Administration Baclofen oral suspension can be administered via a nasogastric (NG) tube at sizes 8 French or larger using the following steps: Ensure the NG feeding tube is flushed with appropriate amount of purified water (15 to 30 mL) prior to administration of baclofen oral suspension. Draw the required dose of baclofen oral suspension in the appropriate oral or enteral syringe and administer the dose via the feeding tube.

The medication may remain in the dosing syringe for up to 4 hours prior to administration. If residual drug remains in the dosing syringe, draw up purified water into the syringe, shake gently, and administer through the feeding tube. Flush the feeding tube with at least 25 mL of purified water.

2.4Discontinuation of Baclofen When discontinuing baclofen, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )] .

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 25 mg per 5 mL (5 mg/mL) baclofen as a concentrated orange to yellow- colored, grape-flavored suspension. Oral Suspension: 25 mg per 5 mL (5 mg/mL) ( 3 )

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen before delivery. ( 5.2 ) Baclofen can cause drowsiness and sedation.

Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. ( 5.3 ) Baclofen can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy.

Use with caution in patients with these conditions. ( 5.5 , 5.6 , 5.7 )

5.1Adverse Reactions from Abrupt Withdrawal of Baclofen Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen is discontinued, unless the clinical situation justifies a rapid withdrawal.

5.2Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and baclofen is continued during pregnancy, gradually reduce the dosage and discontinue baclofen before delivery.

If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.

5.3Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen [see Adverse Reactions ( 6.1 )] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen may be additive to those of alcohol and other CNS depressants.

5.4Poor Tolerability in Stroke Patients Baclofen should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

5.5Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.

5.6Exacerbation of Autonomic Dysreflexia Baclofen should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen may cause an autonomic dysreflexic episode.

5.7Exacerbation of Epilepsy Baclofen should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.

5.8Posture and Balance Effects Baclofen should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

5.9Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were tre…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of Baclofen [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] Ovarian Cysts [see Warnings and Precautions ( 5.9 )] The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group.

Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1 . Table 1.

Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

🔄 Drug Interactions 38 words ▾

7 DRUG INTERACTIONS

7.1CNS Depressants and Alcohol Baclofen can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function. ( 8.6 )

8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations ) . Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] .

Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.

8.2Lactation Risk Summary At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production. Withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen is stopped, or when breastfeeding is stopped [see Warnings and Precautions ( 5.2 )] .

There are no adequate data on other effects of baclofen on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for baclofen and any potential adverse effects on the breastfed infant from baclofen or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations ( 8.6 )] .

8.6Renal Impairment Because baclofen is primarily excreted unchanged through the kidneys, baclofen should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.

🤰 Pregnancy 206 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations ) . Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] .

Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

🧓 Geriatric Use 108 words ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Use in Specific Populations ( 8.6 )] .

🆘 Overdosage 53 words ▾

10 OVERDOSAGE

10.1Symptoms of Baclofen Overdose With overdose of baclofen, patients may present in coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.

10.2Treatment for Overdose The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.

12.2Pharmacodynamics Baclofen has been shown to have general CNS depressant properties, as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 ), and Overdosage ( 10.1 )] .

12.3Pharmacokinetics A pharmacokinetic study in heathy adult male and female subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral suspension and oral tablets. Absorption The peak plasma concentrations of baclofen were achieved in about 1 hour from administration of baclofen oral suspension in the fasted state, and the apparent elimination half-life is about 5.6 hours. Effect of Food Administration of baclofen with a high-fat meal resulted in 9% decrease in AUC and 33% decrease in C max compared to the fasted state.

Elimination Baclofen is excreted primarily by the kidney in unchanged form, and there is relatively large intersubject variation in absorption and/or elimination.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.

📦 How Supplied / Storage and Handling 150 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Baclofen oral suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a concentrated orange to yellow-colored, grape-flavored suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and heat induction layered inner seal. 120 mL, NDC 52536-600-11 300 mL, NDC 52536-600-12

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° and 30° (59° and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.

16.1How Supplied Baclofen oral suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a concentrated orange to yellow-colored, grape-flavored suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and heat induction layered inner seal. 120 mL, NDC 52536-600-11 300 mL, NDC 52536-600-12

📦 Storage and Handling 35 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° and 30° (59° and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.

📋 Description 113 words ▾

11 DESCRIPTION Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 C1NO 2 . Molecular Weight is 213.66 g/mol.

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral suspension inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&C yellow No.

10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose. Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients that baclofen is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy.

Instruct patients to shake before using [see Dosage and Administration ( 2.1 , 2.3 )] . Risks Related to Sudden Withdrawal of Baclofen Advise patients and caregivers not to discontinue use of baclofen without consulting with their healthcare provider because sudden withdrawal of baclofen can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [see Warnings and Precautions ( 5.1 )] . Inform patients that early symptoms of baclofen withdrawal may include increased spasticity, itching, and tingling of extremities.

Neonatal Withdrawal Symptoms Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.2 )] . Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Advise patients that baclofen may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting baclofen or increasing the dose until they know how the drug affects them [see Warnings and Precautions ( 5.3 )] .

Inform patients and their caregivers that the drowsiness associated with baclofen use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their healthcare provider about all prescription and nonprescription drugs they may use. Storage Instruct patients to store baclofen at room temperature and to discard unused portion 2 months after first opening [see How Supplied/Storage and Handling ( 16.2 )] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52536-0530-03 · Wilshire 52536-0625-01 · Wilshire →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.